Clinical trial · Interventional
Extension Study of IMO-8400 in Patients With Waldenström's Macroglobulinemia Who Completed Study 8400-401
An Extension Study to Evaluate the Long-Term Safety, Tolerability, and Clinical Activity of IMO-8400 in Patients With Relapsed or Refractory Waldenström's Macroglobulinemia Who Completed Study 8400-401
NCT02363439CI-TRIAL-00031101completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
An extension study for patients who complete 24 weeks of IMO-8400 on study 8400-401.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Waldenstrom's Macroglobulinemia | Waldenstrom Macroglobulinemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weekly | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg 2xwk
- description
- Subcutaneous injection of IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weekly per Protocol 8400-401
- interventionNames
- Drug: IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weekly
Primary outcomes (1)
- measure
- Number of Participants With Adverse Events
- timeFrame
- During receipt of study treatment on the trial.
- description
- Long term safety and tolerability of IMO-8400 in patients with Waldenstrom's Macroglobulinemia
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Completed 24 weeks of treatment in Protocol 8400-401 Exclusion Criteria: * Grade 3 (or higher) adverse event assessed as treatment-related at any time during the course of treatment under Protocol 8400-401. * Has evidence of disease progression under Protocol 8400-401. * Has received other anti-cancer therapies other than IMO-8400 since enrolling in Protocol 8400-401.
References
Publications (0)
Data not yet available
No reference posted for this study.